Recalls / Class II
Class IID-1281-2014
Product
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.
- Brand name
- Fluoxetine
- Generic name
- Fluoxetine
- Active ingredient
- Fluoxetine Hydrochloride
- Route
- Oral
- NDCs
- 50111-647, 50111-648
- FDA application
- ANDA076001
- Affected lot / code info
- Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15
Why it was recalled
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 72,356 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-02-12
- FDA classified
- 2014-04-28
- Posted by FDA
- 2014-05-07
- Terminated
- 2014-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1281-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.